Insertion device

ABSTRACT

An insertion device, generally used with an infusion set, including a needle being adapted for puncturing at one end and including at the opposite end a hub. The hub includes a handle part and a guard part that are capable of securing the needle through the use of locks. Locking structures are used to secure the insertion device in a position where the needle is covered in a locked position, avoiding unintended contact with the needle.

RELATED APPLICATION DATA

This application is a divisional of U.S. application Ser. No.11/050,101, filed Feb. 3, 2005.

BACKGROUND OF THE INVENTION

1. Field of Invention

Embodiments of the present invention relate generally to an insertiondevice used commonly for subcutaneously puncturing a site in a patientto insert a soft cannula that forms part of an infusion set forsubcutaneous delivery of a fluid, drug or other infusant by means of anexternal infusion system. More particularly, embodiments of theinvention relate to an insertion device capable of being disposed ofwithout the risks of causing unintended harmful injuries to persons.

2. Description of Related Art

Insertion devices are generally used in the field of subcutaneousinfusion sets. These infusion sets are used for delivering a fluid,medication or other infusant, for example, insulin, to a subcutaneoussite in a patient. Such an infusion set is described, for example, inU.S. Pat. Nos. 6,520,938 and 6,056,718, which are herein incorporated byreference. Another example is described in co-pending U.S. applicationSer. No. 11/003,225, entitled Medication Infusion Set, filed on Dec. 3,2004, which is herein incorporated by reference. These devices commonlyinclude a delivery tube connected to an infusion pump or other fluid ormedication delivering device. Such an infusion set may include a baseportion with a cannula deposited in the skin of a patient, and anadhesive patch at the base of the cannula housing to hold the cannula inplace. The cannula is inserted into the skin of a patient, with the aidof an insertion device, to facilitate the subcutaneous transfer of aninfusant. The possibility of disconnecting the infusion set from otherparts of the infusion system is provided in order to improve the usercomfort.

The use of a cannula further improves patient comfort. The cannula isgenerally more flexible than a rigid needle and allows the user toperform activities with much less pain or discomfort. While this allowsfor increased mobility, there remain disadvantages to patients for otherreasons. To insert the cannula in place, an insertion device, commonlyincluding a needle, is used and then discarded after attaching thecannula to the infusion site. Therefore, upon withdrawal of an insertiondevice from the base, there are potential risks of unintended harm fromthe sharp end to the user or others.

Because of the risk of harm during or after disposal of the insertiondevice, it is helpful if the insertion device can be quickly andsecurely covered. And because each insertion device may travel tonumerous locations during the disposal process, and be handled by manydifferent people, it is advantageous if the coverage withstands theentire process and remains secured after it reaches its final disposallocation. Therefore, it would be useful to provide an insertion devicewith a way in which the needle can be covered quickly and securely afteruse and the insertion device discarded without the danger of causingunintended harmful injuries to persons.

While some insertion devices in the art provide ways to cover theexposed needle, there are disadvantages. In general, known insertiondevices involve separate pieces that require the user to fit the piecestogether. The cumbersome assembling process takes additional time andspace. Moreover, the assembling process itself presents additionaldangers of suffering needle pricks. Other known insertion devices, whilenot requiring assembly of separate pieces, involve complicatedmaneuvering to cover and secure the needle. A known insertion device isdescribed in U.S. Pat. No. 6,355,021. The insertion device comprises aneedle and hub. The hub includes a pivotable shield that can bemanipulated to cover the needle as well as interlock the entireinsertion device.

BRIEF SUMMARY

In accordance with an embodiment of the invention, an insertion devicehas been developed that can be used in connection with an externalinfusion system. The insertion device includes a needle at one endadapted for facilitating a subcutaneous puncture and a hub at theopposite end. The hub includes a handle part and a guard part andfurther includes a locking mechanism engaged by the interaction of theguard part and the handle part. The interaction of the guard part andthe handle part facilitate a position wherein the rigid needle iscovered by the guard part.

The insertion device may be used in conjunction with an infusion devicethat has a cannula. The insertion device allows quick and easy placementof the cannula of an infusion set through the skin of the user at aninfusion site to provide a subcutaneous path for an infusant. Anadhesive patch may be included at the base of the cannula housing tohold the placement of the cannula. After the placement of the cannulaand infusion set, the insertion device is removed and the infusant maybe delivered.

Embodiments of the invention may include a hub removably attachable tothe base of a cannula housing of an infusion set. In an unlockedposition, the hub contains a needle housing from which a needle extendsthrough the base. The needle may be subcutaneously insertable into theinfusion site for subcutaneously positioning the cannula. Embodiments ofthe invention include a guard part attached to the hub for covering theneedle after use. The hub of the invention or the parts of the hub maybe made out of a flexible material, such as polypropylene, although itmay also be made out of a non-flexible material, such as polycarbonate,if preferred. Alternatively, the hub of the invention or the parts ofthe hub may be made out of any suitable flexible or non-flexiblematerials such as polyethylene, polyurethane, polyvinyl chloride,resins, polymers, ceramics, composites, or the like.

In one embodiment there is provided a hub removably attachable to thebase of a cannula housing of an infusion set, including a handle partextending from one side of the hub. A guard part, in an unlockedposition, is attached along the handle part and may be slid along ledgeson the inside of the guard part to move in towards the needle. The guardpart moves into the needle, causing the needle to bend into a needlerecess formed as the guard part and the handle part are slid together.Once the guard part slides over the needle and in towards the oppositeend, the locked position of the guard part with the handle part isachieved and the needle is covered. The locked position may be temporaryor permanent. Finger grips comprised of textured ridges on one end ofthe guard part and a finger scoop positioned on the side of the handlepart may be added to improve the user's grip and effectuate handling.

According to an embodiment, the hub and guard part form a needle recessin which the needle may be housed after use. This may be achieved by aguard part with a pocketed cross-section of any shape. The cross-sectionmay include an open space in the middle, or in proximity to the middle,surrounded by the pocket walls of the handle part, except an opening onone side, forming a needle recess along the guard part for the needle toenter. The guard part that fits over the needle recess may facilitatepushing the needle so that it is directed into the needle recess. Theremay be a positive stop further included as a structure at one end of thehub which provides a limit on how far the guard part moves. As the guardpart moves into and over the needle, the guard part continues to movealong the handle part until it reaches the structure and the surface ofthe structure contacts part of the hub. At this point the guard partreaches the positive stop. Additional stops included as part of theguard part may also limit how far the guard part moves.

The guard part and the handle part engage a locking mechanism when thehandle part and the guard part are slid with respect to one another. Thelocking mechanism may be engaged temporarily or permanently. The locksmay include detents on either side of one end of the guard part that fitinto corresponding catches on the inner sides of the handle part. Thedetents can fit into the catches when the guard part is pushed intowards the needle and slid along the needle recess of the handle part.In the locked position, the detents fit into the corresponding catchesand hold the guard part and the handle part in a locked position inwhich the needle is secured inside the needle recess. As anotheralternative, the needle may be secured within the guard part and the hubby alternative locking structures to catches and detents, such as hooks,barbs, or other connecting pieces.

In the embodiment, other safety features may be included. For example, aneedle notch can be placed inside the hub on the end wherein the needletip is directed by the guard part. The needle notch includes a blockthat keeps the needle tip in place. The needle notch further ensuresthat there cannot be unintended contact with the needle tip.

In another embodiment of the invention, a hub removably attachable tothe base of a cannula housing of an infusion set may include a handlepart and a guard part, with a collapse part on one side of the hub and aguard part on the opposite side. The collapse part is attached to a pushblock within the hub. The collapse part is an area on the hub that canflex and collapse inwards when pressure is added. The collapse part maybe composed of any suitable material that will allow it to be flexedwithout fracturing. The opposing walls of the collapse part are biasedto improve the wall collapse when pressure is applied. This inwardcollapse of the walls facilitate the pressure of the collapse part onthe push block. The collapse part causes the push block to flex intowards the needle housing, where the needle resides, pushing the needleso that it bends up into the guard part. The guard part may be extendedto receive and cover the needle, with the guard part having a needlerecess on its underside wherein the needle is received. Catches may bepositioned on opposing sides of the inside of the hub to lock the needlewithin the guard part. When the walls collapse inward, the catchesconnect and hold the walls in the collapsed position. The needle, whichis pushed into the needle recess, is held and secured inside the guardpart in that position. The catches prevent the needle from leaving theguard part once it is pushed into the needle recess of the guard. Thislocked position may be temporary or permanent. As another alternative,the needle may be secured within the guard part by alternative lockingstructures to catches, such as hooks, barbs, or other connecting pieces.Finger grips comprised of textured ridges on the sides of the handlepart may improve the user's grip and effectuate handling.

In yet another embodiment, the hub may include a handle part and a guardpart slidably attached so that the guard part may be movable in relationto the handle part, with the guard part being able to slide over theneedle when grasped and pulled in that direction. As the guard part ispulled over the needle, the needle can be retracted inside the guardpart so that the needle is covered to avoid unintended injuries. Oncethe needle is within the guard, the handle part and the guard part aresecured to one another by a locking mechanism. Detents on the outersides of the handle part and catches on the inner sides of the guardpart may be used to lock the handle part and the guard part. The guardpart is pulled over the needle until the detents and catches correspondand interlock. In the locked position, the needle is secured within theguard part. This position may be temporary or permanent. As anotheralternative to this embodiment, the insertion device may havealternative locking structures to catches and detents, such as hooks,barbs, or other connecting pieces. The hub may be convenientlyconfigured as a single piece so the transition to cover the needlecomprises one sliding motion within one piece. To effectuate thehandling of the insertion device, the guard part may be used along withthe handle part to facilitate the covering of the needle.

These features provide a simple construction that reliably functions toprevent the risk or danger of unintended injuries after the use anddisposal of the insertion device in an efficient and uncomplicatedmanner. Some embodiments may be conveniently configured so that theinsertion device is a single piece, with the guard part and the handlepart movably attached together, but not separable. The configuration mayhelp avoid the complications of assembling multiple pieces.

BRIEF DESCRIPTION OF THE DRAWINGS

A detailed description of embodiments of the invention will be made withreference to the accompanying drawings, wherein like numerals designatecorresponding parts in the figures.

FIG. 1 is a vertical cross-sectional view of an insertion device in anunlocked position according to an embodiment of the invention.

FIG. 2 is a perspective view showing an external configuration of aninsertion device according to an embodiment of the invention.

FIG. 3 is a front end view of an insertion device according to anembodiment of the invention.

FIG. 4 is a rear end view of an insertion device according to anembodiment of the invention.

FIG. 5 is a perspective view showing the bottom of an insertion deviceaccording to an embodiment of the invention.

FIG. 6 is a vertical cross-sectional view of an insertion device wherethe guard part is slid to a locked position, according to an embodimentof the invention.

FIG. 7 is a perspective view showing the external view of an insertiondevice according to an embodiment of the invention.

FIG. 8 is a front end view of an insertion device in the locked positionaccording to an embodiment of the invention.

FIG. 9 is a rear end view of an insertion device in the locked positionaccording to an embodiment of the invention.

FIG. 10 is a perspective view showing the bottom of an insertion devicein the locked position according to an embodiment of the invention.

FIG. 11 is a perspective view where an insertion device is mounted on aninfusion device, according to an embodiment of the invention.

FIG. 12 is a bottom view of an insertion device according to anembodiment of the invention.

FIG. 13 is a vertical cross-sectional view of an insertion deviceaccording to an embodiment of the invention, illustrating the motion ofneedle when it is secured by the guard part and the handle part.

FIG. 14 is a vertical cross-sectional view of an alternative embodimentof the invention showing the manner in which the needle is brought froman unlocked to a locked position within the guard part, according to anembodiment of the invention.

FIG. 15 is a perspective view of an insertion device according to anembodiment of the invention.

FIG. 16 is a perspective view showing the top of an insertion deviceaccording to an embodiment of the invention.

FIG. 17 is a perspective view showing the bottom of an insertion deviceaccording to an embodiment of the invention.

FIG. 18 is a perspective view of an alternative embodiment of theinvention in an unlocked position.

FIG. 19 is a side view of an insertion device according to an embodimentof the invention.

FIG. 20 is a top view of an insertion device in the unlocked positionaccording to an embodiment of the invention.

FIG. 21 is a bottom view of an insertion device according to anembodiment of the invention.

FIG. 22 is a side view showing an insertion device in the lockedposition, according to an embodiment of the invention.

FIG. 23 is a perspective view of an insertion device according to anembodiment of the invention.

DETAILED DESCRIPTION

In the following description, reference is made to the accompanyingdrawings which form a part hereof and which illustrate severalembodiments of the present invention. It is understood that otherembodiments may be utilized and structural and operational changes maybe made without departure from the scope of the present invention.

In FIG. 1, the insertion device shown schematically by the referencenumeral 19 includes a hub 2 having thereon an insertion needle 1. Theneedle 1 is held in place by a needle housing 6 within the hub 2. Theneedle 1 on the end opposite to the hub 2 is pointed or as otherwise tofacilitate puncturing. The hub 2 includes a guard part 4 and a handlepart 3. Along the outer end of the handle part 3, the guard part 4 iscapable of slidably moving along the handle part 3. In one alternative,the handle part 3 protrudes from the hub 2 and is tubular in shape. Thehandle part 3 may include a pocketed cross-section that forms a needlerecess (not shown). In FIG. 3 and FIG. 5, the handle part 3 furtherincludes ledges 12 and 13 on either side of the tubular shape which holdthe guard part 4 and allows it to slide laterally along the handle part3. As shown in FIG. 5, the guard part 4 may continue to slide laterallyuntil positive stops 22 and 23 are reached. The positive stops 22 and 23may be created by a structure attached at one end of the guard part 4and the hub 2 that come into contact when the guard part 4 slides farenough to cover the entire needle 1. The positive stops 22 and 23provide a limit on how far the guard part 4 may move. Other types ofstops may also be used to limit how far the guard part moves.

In FIG. 1, the housing 6 for the needle 1 in the hub 2 is apparent. Theneedle housing 6 may have a circular, square or any desiredcross-sectional shape. The needle 1 may be securely held in position bya press fit connection, by gluing or welding, or by being insert molded.The hub 2 of the insertion device 19 is preferably manufactured from asuitable material that flexes, such as polypropylene. However, the hubmay also be made out of a non-flexible material, such as polycarbonate,if preferred. Alternatively, the hub may be made out of any suitableflexible or non-flexible materials such as polyethylene, polyurethane,polyvinyl chloride, resins, polymers, ceramics, composites, or the like.Additionally, a finger scoop 14 on the side of the handle part 3 andfinger grips 15 and 16 comprising textured ridges on one end of theguard part 4 may be included to improve the user's grip and handling, asshown in FIG. 1 and FIG. 2, respectively.

In FIG. 13, the guard part 4 may be slid along the ledges (not shown) ofthe handle part 3 in towards the needle 1, causing the needle 1 to bebent and pushed into the needle recess 11 formed between the handle part3 and the guard part 4. Once the guard part 4 slides over the needle 1and in towards the needle 1, as shown in FIGS. 6-10, the locked positionof the handle part 3 and the guard part 4 is engaged where the needle 1is covered. The locked position may be temporary or permanent.Additional safety features may be included. Shown in FIG. 13, a needlenotch 17 may be located inside the guard 4 where the needle tip 1A isdirected when the needle 1 is bent into the needle recess 11. The needlenotch 17 may comprise a block that keeps the needle tip 1A in place. Theneedle notch 17 stabilizes and further secures the needle tip 1A.

In the unlocked position, as shown in FIGS. 1-5, the guard part 4 is inthe unlocked position at the end of the handle part 3 away from theneedle housing 6. The needle 1 is not covered and the locking mechanismis not engaged. In this unlocked position, the insertion device 19 maybe used to puncture the skin of a patient.

In FIG. 10, the locks are detents 7 and 8 and catches 9 and 10 which areengaged once the handle part 3 and the guard part 4 are slid together asfar as the positive stops 22 and 23 to secure the handle part 3 and theguard part 4 in that position. Detents 7 and 8 on either side of one endof the guard part 4 will fit into corresponding catches 9 and 10 on theinside of the handle part 3, when the guard part 4 slides along theneedle recess 11 formed with the handle part 3, as the guard part 4slides towards the needle 1 to secure the guard part 4 and the handlepart 3 together. In the locked position, as shown in FIG. 10, thedetents 7 and 8 will catch into the corresponding catches 9 and 10 andbe held in the locked position. The needle 1 will be secured inside theneedle recess 11. In other alternatives, the number of detents andcatches may be varied. For example, one alternative locking structuremay have one detent with one catch to connect. Additionally, anembodiment may use alternative locking structures to catches anddetents, such as hooks, clips, or other connecting pieces.

In FIG. 3 and FIG. 4, which are the front and rear views, respectively,the needle recess 11 of the handle part 3 and its interaction with theguard part 4 appears more clearly. The configuration of the needlerecess 11 includes an open space in the middle surrounded by the handlepart 3, except an opening on one side. The needle recess 11 is formedalong the handle part 3 for the needle 1 to enter. The guard part 4 isadapted to slide along the ledges 12 and 13 of the handle part 3 to formthe needle recess 11 with the handle part 3. The ledges 12 and 13 oneither side of the handle part 3 interact with the guard part 4 tofacilitate the sliding motion towards the needle housing 6 needed toreach the locked position. The locked position with the needle 1 securedmay be disposed substantially at the end of the insertion device 19 thatis opposite to the end from where the guard part 4 initially moves. Inalternative embodiments, the number of ledges may be varied. Forexample, in one alternative insertion device, the handle part may haveone inner ledge on which the guard part slides.

In FIG. 11 and FIG. 12, a field of use for the insertion device 19appears. The insertion device 19 is provided for quick and easyplacement of a subcutaneous infusion set 20, and may then be discardedsafely. The infusion set 20 with a cannula 21 extending therefrom isshown. An adhesive patch (not shown) may also be provided to hold thecannula in place once it is deposited in the skin of the patient. Theother embodiments may also be used with an infusion set in this manner.

The invention provides a ready to use insertion device, which may bemolded from a suitable material that is flexible, such as polypropylene.However, the device may also be made out of a non-flexible material suchas polycarbonate. Alternatively, the device may be made out of anysuitable flexible or non-flexible materials such as polyethylene,polyurethane, polyvinyl chloride, resins, polymers, ceramics,composites, or the like. An infusion device assembly shown in FIG. 11and FIG. 12, as delivered from the manufacturer, including the insertiondevice 19 may conveniently effectuate the placement of an infusiondevice 20 as the assembly provides an insertion device 19 alreadymounted on the insertion needle 1. This may help reduce the time neededfor the placement of an infusion set. Furthermore, because the insertiondevice 19 includes a guard part 4, it is convenient for the user tocover and secure the needle 1 prior to disposal. As best seen in FIG.13, FIG. 14, and FIG. 23, each embodiment may be brought to lockedpositions prior to disposal, thereby avoiding unintended harmfulinjuries caused by an exposed needle.

An alternative embodiment of the invention is shown schematically inFIGS. 14-17. FIGS. 14-17 serve the purpose of explaining the principlesinvolved in that embodiment, and the figures show schematic andcross-sectional views of the insertion device 119.

In FIG. 14, the insertion device is shown schematically by the referencenumeral 119. FIG. 14 is a vertical cross-sectional view showing themanner in which the needle 101 is brought to a locked position withinthe guard part 104. This locked position may be temporary or permanent.In the unlocked position, the insertion device 119 may be used topuncture a site in a patient. FIG. 14 shows the insertion device 119with a hub 102 that includes a guard part 104 and a handle part 103. Thehub 102 further includes an insertion needle 101, which is held in placeby a needle housing 106 within the hub 102. The needle housing 106 mayhave a circular, square or any desired cross-sectional shape. The needle101 may be securely held in position by a press fit connection, bygluing or welding, or by being insert molded. The hub 102 of theinsertion device 119 is preferably manufactured from a suitable materialthat flexes, such as polypropylene. However, the hub may also be madeout of a non-flexible material, such as polycarbonate, if preferred.Alternatively, the hub may be made out of any suitable flexible ornon-flexible materials such as polyethylene, polyurethane, polyvinylchloride, resins, polymers, ceramics, composites, or the like. Theneedle 101 on the end opposite to the hub 102 is pointed or as otherwiseto facilitate puncturing.

In FIG. 14, a collapse part 120 is shown on one side of the hub 102. Thehub 102 includes a handle part 103 and a guard part 104, with thecollapse part 120 attached to a push block 123 inside the hub 102. Thecollapse part 120 may be made of a plastics material that allowsflexibility, so that pressure applied to the collapse part 120 causes itto be flexed, moving the push block 123 in towards the needle housing106 in which the needle resides. The guard part 104 may include a needlerecess 111 on its underside wherein the needle 101 is received andsecured in place by catches (not shown). The guard part 104 may beextended to receive and cover the needle 101.

In FIG. 17, the catches 109 and 110 are seen to be positioned onopposing sides of the inside of the hub 102 to lock the needle (notshown) within the guard part 104. When the walls 121 and 122 collapseinward, the catches 109 and 110 connect and hold the walls 121 and 122in the collapsed position. The needle 101, which is pushed into theneedle recess 111, is held and secured inside the guard part 104 in thatposition. The catches 109 and 110 hold the walls 121 and 122 in thecollapsed position to prevent the needle 101 from leaving the guard part104 once it is pushed into the needle recess 111 of the guard 104. Toeffectuate the handling of the insertion device 119, the guard part 104may comprise finger grips on the handle part 103 to facilitate thecovering of the needle (not shown).

In FIG. 15 the external configuration of the insertion device 119 in thelocked position can be seen more clearly. The collapse part 120 includeswalls 121 and 122 opposite to one another that collapse when pressure isapplied to the collapse part. The walls further include an angling ofmaterial at the top of the collapse part to form biases 124 and 125. Thebiases 124 and 125 help improve the wall collapse when the pressure isapplied. As shown in FIG. 14, this collapse facilitates the moving ofthe push block 123, which in turn, pushes the needle 101 up into theguard part 104.

The top view of the insertion device 119 can be seen in FIG. 16. Thebottom view of the insertion device 119 is illustrated in FIG. 17. Thetwo views show the insertion device 119 in the unlocked position. Theviews show how the walls 121 and 122 are positioned to facilitate movingthe push block 123 into the needle housing 106 so as to push the needle101 into the guard part 104. When the needle 101 is within the guardpart 104, the catches 109 and 110 secure the walls 121 and 122 in thecollapsed position to lock the needle 101 inside. In other alternatives,the number of catches may be varied. For example, one alternativelocking structure may have more than two catches to lock. Additionally,an embodiment may use alternative locking structures to catches, such assuch as hooks, clips, or other connecting pieces.

In FIGS. 18-23, a further embodiment of the invention is illustrated.FIGS. 18-23 serve the purpose of explaining the principles involved inthat embodiment, and the figures show schematic and partialcross-sectional views of an insertion device 219.

In FIG. 18 and FIG. 19, the insertion device shown schematically by thereference numeral 219 shows a hub 202 removably attachable to the baseof a cannula housing of an infusion device (not shown) that includes aguard part 204 and a handle part 203. The hub 202 further includes aninsertion needle 201 to facilitate puncturing. The insertion device 219is shown in the unlocked position. The configuration of the hub 202,including the handle part 203 and the guard part 204 connected togetherin one piece, is illustrated. The handle part 203 and the guard part 204are slidably attached so that the guard part 204 may be pulled and slidalong the handle part 203 over the needle 201, covering the needle 201to avoid unintended injuries. Pulling the guard part 204 over the needle201 allows the needle 201 to be retracted inside the guard part 204. Asshown in FIG. 22 and FIG. 23, once the needle 201 is within the guardpart 204, the handle part 203 and the guard part 204 are secured by alocking mechanism that may include detents 207 and 208 on the outersides of the handle part 203 and catches 209 and 210 on the inner sidesof the guard part 204. The locked position may be temporary orpermanent.

In FIG. 18 and FIG. 19, the unlocked position is shown where the needle201 is exposed and the insertion device 219 may be used to puncture. Inthis position the locking mechanism is not engaged. From FIG. 21, whichshows the bottom view, the inside of the needle recess 211 appears moreclearly. The needle 201 may be retracted into the needle recess 211 whenthe guard part 204 is pulled over the needle 201. When the entire needle201 is within the guard part 204, the detents 207 and 208 and catches209 and 210 may lock the handle part 203 to the guard part 204, securingthe needle 201 inside. In other alternatives, the number of detents andcatches may be varied. For example, one alternative locking structuremay have one detent with one catch to connect. Additionally, anembodiment may use alternative locking structures to catches anddetents, such as such as hooks, clips, or other connecting pieces.

In FIG. 20 and FIG. 21, the top and bottom views, respectively, of theexternal side of the housing 206 for the needle 201 in the hub 202 ismore apparent. The needle housing 206 may have a circular, square or anydesired cross-sectional shape. The needle 201 may be securely held inposition by a press fit connection, by gluing or welding, or by beinginsert molded. The hub 202 of the insertion device 219 is preferablymanufactured from a suitable material that flexes, such aspolypropylene, although a non-flexible material, such as polycarbonate,may also be used if preferred. Alternatively, the hub of the insertiondevice may be made out of any suitable flexible or non-flexiblematerials such as polyethylene, polyurethane, polyvinyl chloride,resins, polymers, ceramics, composites, or the like.

FIGS. 22-23 show the insertion device 219 in the locked position, wherethe needle 201 is secured within the guard part 204. The hub 202 isconveniently configured as a single piece where the transition betweenthe handle part 203 and the guard part 204 includes one sliding motionwithin one piece, avoiding the assembling of separate parts whencovering the needle 201. Detents 207 and 208 on the outer sides of thehandle part 203 and catches 209 and 210 on the inner sides of the guardpart 204 facilitate the locked position of the insertion device 219. Theguard part 204 is pulled over the needle 201 until the detents 207 and208 lock the handle part 203 and the guard part 204. To effectuate thehandling of the insertion device 219, the guard part 204 may be used inconjunction with the handle part 203.

While the description above refers to particular embodiments of thepresent invention, it will be understood that many modifications may bemade without departing from the spirit thereof. The accompanying claimsare intended to cover such modifications as would fall within the truescope and spirit of the present invention.

The presently disclosed embodiments are, therefore, to be considered inall respects as illustrative and not restrictive, the scope of theinvention being indicated by the appended claims rather than theforegoing description. All changes that come within the meaning of andrange of equivalency of the claims are intended to be embraced therein.

1. An insertion set, comprising: a cannula housing of an infusion setincluding a cannula adapted to be inserted into the skin of a patient;and an insertion device including: a hub removably attachable to a baseof the cannula housing of an infusion set, said hub including a handlepart and a guard part; and a needle attached to the hub, wherein theguard part is adapted to slide along the handle part according to adirection pulled to cover the needle, said direction being parallel tothe needle's longitudinal axis.
 2. The insertion set of claim 1, whereinthe needle is adapted to extend through the cannula of the cannulahousing and beyond an outer tip thereof when the insertion device isattached to the cannula housing.
 3. The insertion set of claim 1,wherein the guard part and the hub form a needle recess to house theneedle.
 4. The insertion set of claim 1, wherein the insertion devicefurther includes locks adapted to secure the needle in the guard partwhen the needle is covered by the guard part.
 5. The insertion set ofclaim 4, wherein the locks are adapted to interlock the guard part withthe handle part when the guard part is slid over the needle.
 6. Theinsertion set of claim 5, wherein the locks are detents on outer sidesof the handle part and catches on inner sides of the guard part thatcorrespond to the detents.
 7. The insertion set of claim 6, wherein thedetents snap into the catches when the guard part is slid along thehandle part over the needle to lock the guard part and the handle parttogether wherein the needle is covered.
 8. An insertion device,comprising: a hub removably attachable to a base of a cannula housing ofan infusion set, said hub including a handle part and a guard part; anda needle attached to the hub, wherein the guard part is adapted to slidealong the handle part according to a direction pulled to cover theneedle, said direction being parallel to the needle's longitudinal axis.9. The insertion device of claim 8, further including locks adapted tosecure the needle in the guard part when the needle is covered by theguard part.
 10. The insertion device of claim 9, wherein the locks areadapted to interlock the guard part to the handle part when the guardpart is slid over the needle.
 11. The insertion device of claim 10,wherein the locks are detents on outer sides of the handle part andcatches on inner sides of the guard part that correspond to the detents.12. The insertion device of claim 11, wherein the detents snap into thecatches when the guard part is slid along the handle part over theneedle to lock the guard part and the handle part together wherein theneedle is covered.
 13. The insertion device of claim 8, wherein theneedle is adapted to extend through a cannula of the cannula housing andbeyond an outer tip thereof when the insertion device is attached to thecannula housing.
 14. The insertion device of claim 8, wherein the guardpart and the hub form a needle recess to house the needle.
 15. A methodfor covering an insertion needle, comprising: inserting a cannula intothe skin of a patient with an insertion device, wherein the insertiondevice includes: a hub removably attachable to a base of a cannulahousing of an infusion set, said hub including a handle part and a guardpart; and a needle attached to the hub, wherein the guard part isadapted to slide along the handle part according to a direction pulledto cover the needle, said direction being parallel to the needle'slongitudinal axis; removing the insertion device from the cannulahousing; and sliding the guard part along the handle part in saiddirection parallel to the needle's longitudinal axis so as to cover theneedle with the guard part.
 16. The method of claim 15, wherein theinsertion device further includes locks adapted to secure the needle inthe guard part when the needle is covered by the guard part.
 17. Themethod of claim 16, wherein the locks are adapted to interlock the guardpart to the handle part when the guard part is slid over the needle. 18.The method of claim 17, wherein the locks are detents on outer sides ofthe handle part and catches on inner sides of the guard part thatcorrespond to the detents.
 19. The method of claim 18, wherein thedetents snap into the catches when the guard part is slid along thehandle part over the needle to lock the guard part and the handle parttogether wherein the needle is covered.
 20. The method of claim 16,wherein the needle is locked within the guard part before disposing ofthe insertion device.
 21. The method of claim 15, wherein the needle isadapted to extend through the cannula of the cannula housing and beyondan outer tip thereof when the insertion device is attached to thecannula housing.
 22. The method of claim 15, wherein the guard part andthe hub form a needle recess to house the needle.